Device evidence

device-recall:cfres:156069

Pointe Scientific Liquid Creatine Kinase Reagent Set Device is a kit comprised of two reagents an R 1 Buffer and R2 CK enzyme solution. Intended Use: For the kinetic quantitative determination of creatine kinase activity in serum.

Official recall number

Z-2650-2017

Evidence summary

Product code: CGS
Recall status: Terminated
Event initiated: October 19, 2011
Root cause: Labeling Change Control
Source snapshot: d51b4b87fdeb9ccf809d8b814d67f3a0fa43ac67bead6c171fe27284699c3275
Product: Z-2650-2017